Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Tuesday, June 19, 2018 Daily Archives

Patheon is doubling its biomanufacturing capacity through a $50 million investment in Missouri. We spoke with the CDMO about the continued demand for biologics services and its relationship with owner Thermo Fisher. In April, contract development and manufacturing organization (CDMO) Patheon announced plans to add 16,000 L of single-use capacity at its St Louis, Missouri facility. The US$50 million (€43 million) expansion effectively doubles the firm’s global biomanufacturing capacity. According to David Kenyon, senior director of Global Scientific and Technical…

Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter​ sent to the firm in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…